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FDA 510(k)

ScanX Swift 2.0, ScanX Swift View 2.0

K-Number: K230095 · 2023-02-06

ApplicantDurr Dental SE
Decision Date2023-02-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ScanX Swift 2.0, ScanX Swift View 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2023-02-06 under 510(k) number K230095. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScanX Swift 2.0, ScanX Swift View 2.0?

ScanX Swift 2.0, ScanX Swift View 2.0 is a medical device that received FDA 510(k) clearance on 2023-02-06. The listed applicant is Durr Dental SE. The 510(k) number is K230095.

When did ScanX Swift 2.0, ScanX Swift View 2.0 receive FDA 510(k) clearance?

ScanX Swift 2.0, ScanX Swift View 2.0 received FDA 510(k) clearance on 2023-02-06, under 510(k) number K230095.

Who is the listed applicant for ScanX Swift 2.0, ScanX Swift View 2.0?

The FDA 510(k) record lists Durr Dental SE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ScanX Swift 2.0, ScanX Swift View 2.0?

The FDA product code for ScanX Swift 2.0, ScanX Swift View 2.0 is MUH.

Other records listing Durr Dental SE as applicant

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Related Devices (Code: MUH)

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K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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